Post marketing sureillance study to evaluate safety and performance of the MOZECâ?¢ Sirolimus Eluting Percutaneous Transluminal Coronary Angioplasty Balloon Dilatation Catheter for patients with new coronary native artery blockage.
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2017/03/008002
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
The Patient should meet all of the Inclusion Criteria.
1. Patient must be at least 18 years of age.
2. Patient or his or her legally authorized representative (LAR) has provided written informed consent.
3. Patient should be able to comply with protocol requirements and assessments.
4. Female Patient of childbearing potential who does not plan pregnancy for up to 2 years from the date of index procedure. For a female Patient of childbearing potential a pregnancy test must be performed with negative results at screening visit.
5. Female Patient is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 2 years from the date of index procedure.
6. Patient agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure.
7. Target reference vessel diameter of lesions must be from 2.00 milimeter to 4.50 milimeter in diameter by visual estimate.
8. Target Lesion greater than 50 percent and less than 100 percent stenosed and length should be less than 30 milimeter by visual estimate.
9. Patients with Target lesion located in a native coronary artery where,
- Dilatation required in de-novo stenotic portion or
- Dilatation required in totally occluded stenotic portion or
- Dilatation required in stenotic portion of In-Stent Restenosis presented either with Bare Metal Stent (BMS) or with Drug Eluting Stent (DES) or
- Post dilatation required in case of balloon expandable stents.
10. The target lesion must be covered by a single MOZEC SEB PTCA Balloon.
11. Patient with single vessel or multiple vessel disease.
The Patient meeting any of the Exclusion Criteria will not be included in the study.
1. Patient has a known medical history of allergy against appropriate anticoagulation/antiplatelet therapy.
2. Patients with known medical history of allergy against aspirin, Sirolimus (Rapamycin) and its excipients hydrogenated castor oil and ployvinylpyrrolidone (PVP) or any contrast media.
3. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
4. Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.
5. Coronary artery spasm in the absence of a significant stenosis.
6. Patients participate in other clinical trials involving any investigational device or drug.
7. Lesions in bypass grafts or saphenous vein grafts.
8. Patients with a target lesion that was previously treated by coronary brachytherapy (that is to reduce the recurrence of blockage of a coronary artery by radiation).
9. Patient has life expectancy less than 2 years for any non-cardiac cause or cardiac cause.
10. Vulnerable patients.
11. Patient has a chronic renal insufficiency with serum creatinine level of more than 2.0 miligram per decilitre or 160 milimoles per litre at the time of screening (1 week prior to index procedure).
12. Patients having concomitant medical illnesses that require cytostatic or radiation therapy that might cause patient to be
noncompliant with the protocol.
13. Unprotected left main coronary artery lesions.
14. Patient has a platelet count less than 100,000 cells per milimeter cube or greater than 700,000 cells per milimeter cube.
15. Patient presents with cardiogenic shock.
16. History of stroke within the prior 6 months
17. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
18. Patient is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is
unsuitable for the study for any reason.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events (MACE), Number of AE/SAE related to study deviceTimepoint: At Baseline, post-procedure and discharge, 1 month (±14 days), 6 months (±28 days), 12 months (±28 days) and 24 months (±28 days) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Change in Late Lumen Loss (LLL) <br/ ><br>2. Clinical success <br/ ><br>3. Device Success <br/ ><br>4. User Rating on Technical Properties <br/ ><br>Timepoint: 1. At post procedure and after 6 months (±28 days) <br/ ><br>2. At Baseline <br/ ><br>3. Directly after intervention <br/ ><br>4. At Baseline <br/ ><br>